Identity
- Trade Name
- X-MIND unity FDA UDI
- Generic Name
- Stationary intraoral dental x-ray system, digital FDA UDI
- Device Name
- The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-MIND unity is an extra-oral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of the teeth, jaw and oral structures. FDA UDI
- Model / Reference
- XMU CORE KIT VET SC NO BRACKET FDA UDI
- Description
- The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-MIND unity is an extra-oral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of the teeth, jaw and oral structures. FDA UDI
Identifiers
- Catalog Number
- W0800083 FDA UDI
- Primary DI / UDI-DI
- D804W08000830 FDA UDI
- 510(k) Number
- K132378 FDA UDI
- FDA Product Code
- EHD FDA UDI
- GMDN Term
- Stationary intraoral dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stationary intraoral dental x-ray system, digital
X-MIND unity by De Götzen Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Stationary intraoral dental x-ray system, digital.
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- Midmark PREVA 2.0 IntraOral Dental X-ray System — Midmark Corporation · Class II
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- Midmark — Midmark Corporation · Class II
- Owandy-RX DC — OWANDY RADIOLOGY · Class II
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Cleared under the same submission
K132378 also covers:
- X-MIND unity — DE GÖTZEN SRL
- X-MIND unity — DE GÖTZEN SRL
- X-MIND unity — DE GÖTZEN SRL
- X-MIND unity — DE GÖTZEN SRL
- X-MIND unity — DE GÖTZEN SRL
- X-MIND unity — DE GÖTZEN SRL
- X-MIND unity — DE GÖTZEN SRL
- X-MIND unity — DE GÖTZEN SRL
- X-MIND unity — DE GÖTZEN SRL
- X-MIND unity — DE GÖTZEN SRL
- X-MIND unity — DE GÖTZEN SRL
- X-MIND unity — DE GÖTZEN SRL
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- De Götzen Srl
Sources (1)
- FDA UDI 5fec1b45-d4e4-422a-9f3a-12f1d674c198 37 fields · synced May 30, 2026